As you will be aware my FOI request from 27th November 2013 was declined, and that decision was upheld by the information commissioner, as it was decided that by law that requesting a calculation meant counted in this case as not 'holding the data'. The commissioner, however recommended to me that I ask for the raw data, because as, he established through a conversation with you, this is data that you do hold.

Therefore I would like to request, (for the participants for whom you have data), the 6 min walking test results both before treatment and at follow-up for:

Thank you for your emails of 30^th and 31^st May requesting information
relating to the PACE trial.

You asked, “I would like to request, (for the participants for whom you
have data), the 6 min walking test results both before treatment and at
follow-up for:

1) Those who are recovered according to your published criteria. I would
like the data requested to be broken down into treatment type (as per your
publications - CBT, GET, Adaptive pacing etc)”.

After due consideration we are refusing your request. Section 14(1) of the
Freedom of Information Act 2000 states that public authorities are not
obliged to comply with a request for information if that request is
vexatious.

In accordance with s.17, please accept this as a refusal notice.

If you are dissatisfied with this response, you may ask QMUL to conduct a
review of this decision. To do this, please contact the College in
writing (including by fax, letter or email), describe the original
request, explain your grounds for dissatisfaction, and include an address
for correspondence. You have 40 working days from receipt of this
communication to submit a review request. When the review process has
been completed, if you are still dissatisfied, you may ask the Information
Commissioner to intervene. Please see [1]www.ico.org.uk for details.

Elizabeth Unger's talk at the recent 2014 Stanford ME/CFS Symposium on the epidemiology of this illness made it clear that ME/CFS is a major public health issue, expensive both to the economy in terms of lost labour (both domestic and in work settings), and in human distress. Her charts show that patients have disability ratings more severe than those with MS, cancer, chronic pelvic pain, lung disease. Interestingly, contrary to the widespread belief that ME/CFS has a psychiatric component, Unger's charts show that ME/CFS patients scores are relatively high on the two indicators of mental health. Many studies, and a long history of patient reports indicated that ME/CFS has an underlying pathology which makes exercise dangerous to them. All symptoms worsen, and many patients have been made permanently, severely ill after conscientious attempts to follow exercise programs. The PACE Trial purports to support treatment aimed at 1) persuading patients that they do not have a physical illness (CBT) and 2) that they will benefit from a program of graded exercise therapy similar to those employed in rehabilitation of patients after injury.The information publicly available about this trial indicates a number of changes to the original protocol, including a decision not to use a physical measure of activity, and a change to the criteria for recovery from 85 to 60, when the criteria for being ill enough to enter the trial was 65. The results of this study are being described as evidence-based proof that patients will get better as a result of these two therapies, and are included in the NICE Guidelines for treatment of ME/CFS.If this were a drug trial, it would be evident that patients need to be protected from the effects of treatment based on flawed research. If a drug company were reluctant to give public access to information about the physical state of patients who had been treated by their drug, a drug recommended for the treatment of a severe illness affecting large numbers of patients, such an enquiry would not be dismissed as 'vexatious'. It is difficult to believe that if the information requested supported the conclusions which the researcher has reported, he would want it to be witheld.

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Queen Mary, University of London's handling of my FOI request 'Raw data for 6mwt'.
I am particularly surprised that you see my request as vexatious - it is certainly not my intention. Rather, this is important information that I am sincerely interested in, and which I know that you hold. I would like to point out again, that while my previous request was refused, the Information Commissioner himself recommended that I make this new request asking for the raw data.

As a scientist, I am seeking to understand the full implications of the research that you have conducted. As a patient, the distance that I can walk is of incredible concern, and has huge implications for activities that I can undertake and therefore quality of life. When deciding to undertake a treatment such as CBT or GET, it is surely not unreasonable to want to know how far the patients who have recovered using these treatments can now walk. Again, I know you have this data, and believe strongly that it would be in the public interest for it to be released.

I would be grateful if you could reconsider this request, and provide reasons why you think the request is considered vexatious.

In my annotation above, I referred to a presentation given by Elisabeth Unger. It occurred to me that not everyone will be aware of her credentials. This is a report from the U.S. Center for Disease Control, announcing her appointment, in December, 2013:

'Elizabeth (Beth) Unger, PhD, MD, has been selected to serve as the Chief of the Chronic Viral Diseases Branch (CVDB) in the Division of High-Consequence Pathogens and Pathology (DHCPP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

'Dr. Unger has served as the Acting Chief of CVDB since January 2010 and has 13 years of experience in CVDB, where she has participated in the design and implementation of CFS research and HPV laboratory diagnostics.

'During this time, she was co-author on 25 peer-reviewed manuscripts related to CFS, including the often-cited descriptions of the Wichita and Georgia population-based studies. In addition, Dr. Unger has been instrumental in efforts by WHO to establish an HPV LabNet and serves as lead of a WHO HPV Global Reference Laboratory.

'She is co-author of 142 peer-reviewed publications and 24 book chapters and serves on the editorial board of six scientific journals. In 2008, for her HPV research accomplishments, she received the Health and Human Services (HHS) Career Achievement Award.

'Dr. Unger received an undergraduate degree in Chemistry at Lebanon Valley College, Annville, PA. She then earned her PhD and MD in the Division of Biologic Sciences at the University of Chicago where she also began a residency in pathology. Her residency and fellowship was completed at Pennsylvania State University Medical Center. During this time, Dr. Unger developed a practical method of colorimetic in situ hybridization. This work led to interest in tissue localization of HPV and ultimately to her initial appointment to CDC in 1997 to pursue molecular pathology of HPV and CFS.'

It would seem obvious that her scientific and professional status indicates that information she provides should be taken very seriously indeed. No doubt Professor White is highly regarded in his field (psychiatry), but it is evident from the positioning of CFS alongside other viral research within Dr. Unger's remit that the U.S. CDC does not regard psychiatry as relevant to ME/CFS.

1 Attachment

Queen Mary has been conducting its internal review on this request and we
apologise for the delay. The review has determined that the request is not
vexatious.

In the light of this we have reassessed your request.

We do not hold the precise data you have requested i.e. for recovered
patients. To provide this would exceed the appropriate limit as defined by
the Freedom of Information and Data Protection (Appropriate Limit)
Regulations 2004. For your information this is £450, calculated as the
estimated cost of one person spending 18 hours in determining whether the
information is held, then locating, retrieving and extracting the
information. Section 12 of the Freedom of Information Act 2000 therefore
makes provision for public authorities to refuse such requests.

Data relating to the six minute walking test has been published in summary
form in the original Lancet paper of 2011 in Table 6, please see attached.

If you remain dissatisfied you have the right to appeal to the Information
Commissioner's Office. Please see [1]www.ico.org.uk for details.